Insmed Q3 2020 Earnings Report
Key Takeaways
Insmed reported a productive third quarter with significant progress across its programs. ARIKAYCE performance was maintained in the U.S., marketing authorization was granted in the European Union, and an sNDA was approved by the U.S. FDA. Plans to initiate a global Phase 3 study of brensocatib in NCFBE and a Phase 1 study of TPIP were also advanced.
ARIKAYCE total revenue was $43.6 million for the third quarter of 2020.
Marketing authorization for ARIKAYCE Liposomal 590 mg Nebuliser Dispersion was granted in the European Union.
A supplemental New Drug Application (sNDA) was approved by the U.S. FDA for ARIKAYCE, adding culture conversion data beyond 12 months to the label.
Three key clinical trials are expected to begin by the end of 2020: Phase 3 ASPEN Study of Brensocatib in Non-Cystic Fibrosis Bronchiectasis (NCFBE), Pivotal ENCORE Study of ARIKAYCE in Front-Line NTM, and ARISE Study to Validate PRO Tool in NTM.
Insmed
Insmed
Forward Guidance
Insmed anticipates continuing to invest in key activities in 2020.